MODIFICATION
65 -- MEDICAL COUNTERMEASURES TO MITIGATE AND/OR TREAT NEUTROPENIA ALONE OR IN COMBINATION WITH CO-MORBIDITIES ASSOCIATED WITH ACUTE RADIATION SYNDROME (ARS).
- Notice Date
- 11/18/2005
- Notice Type
- Modification
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
- ZIP Code
- 20201
- Solicitation Number
- DHHS-ORDC-DDA-05-12
- Archive Date
- 12/31/2005
- Description
- BACKGROUND: The National Response Plan designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical responses to man-made or natural disasters. The HHS Office of Public Health Emergency Preparedness (OPHEP) was established in 2002. This office holds responsibility for implementation of a comprehensive HHS strategy to protect the American population from, and be prepared to respond to, acts of bioterrorism and other public health emergencies. Specifically, the Office of Research and Development Coordination (ORDC) within OPHEP has the responsibility within HHS to contract with industry for large-scale manufacturing and delivery of licensable products to the Strategic National Stockpile (SNS) in preparation for a public health emergency response. DESCRIPTION: The purpose of this notice is to indicate that HHS anticipates publishing a Request for Proposal (RFP) for acquisition of product on or after December 5, 2005. The Department of Health and Human Services has a requirement for the acquisition and maintenance of therapeutic products to mitigate and/or treat the hematopoietic disruptions associated with Acute Radiation Syndrome (ARS). ARS, also referred to as radiation sickness, is an acute illness caused by radiation delivered to the whole body (or a large proportion of the body) over a period of seconds to days. In addition ingested, inhaled, or absorbed radioisotopes could also produce ARS. There are several blood-cell types that are primarily affected in ARS including white cells (neutrophils and lymphocytes), red cells, and platelets. The significant decrease of neutrophils (called neutropenia) significantly increases an individual's susceptibility to lethal infections. Severe thrombocytopenia and anemia, (a lack of platelets and red blood cells respectively) can significantly increase an individual's risk for bleeding (at platelet levels <20,000/uL) or tissue ischemia due to loss of oxygen carrying capacity, respectively. The current requirement is for the acquisition of up to 100,000 treatment courses of medical countermeasures to mitigate and/or treat the hematopoietic syndrome associated with ARS; THE TREATMENTS TO BE ACQUIRED MUST MITIGATE AND/OR TREAT NEUTROPENIA. Following whole body radiation exposure in the 2 to 6 Gy range, treatment of neutropenia is the most critical clinical requirement and thus Offerors' product(s) must mitigate and/or treat neutropenia associated with ARS. Medical countermeasures that both treat and/or mitigate the other components of the hematopoetic syndrome and/or the gastrointestinal syndrome of ARS are of interest to the USG. The gastrointestinal syndrome facilitates the transmigration of the intestinal flora placing patients with neutropenia at increased risk of life-threatening bacteremia and sepsis. The Technical Evaluation Criteria to be published in the RFP will establish a scoring system whereby those products that can address additional components of ARS in addition to neutropenia (including thrombocytopenia, anemia, lymphopenia, GI syndrome, etc.) will be given additional points. This acquisition is based on the availability of funds. The RFP to be issued will be on the basis of full and open competition. Subcontracting with small and small disadvantaged business is encouraged. All Offerors with a candidate product or products for the mitigation and/or treatment of neutropenia alone or neutropenia in combination with one or more additional components of ARS that meet the Mandatory Criteria for Eligibility specified in the RFP are encouraged to submit a proposal in response to the RFP. The Mandatory Criteria for Eligibility will include: Product(s) that treat the neutropenia associated with ARS. Neutropenia will be defined as a reduction in neutrophils (granulocytes) meeting one of the following criteria: o Moderate <1000 neutrophils/uL o Severe <500 neutrophils/uL The Government reserves the right to make single or multiple contract awards. It is anticipated that up to an additional 100,000 treatment courses may be acquired under SEPARATE RFP(s) at a later date, contingent on the availability of funds. The RFP will be released on GSA FEDBIZOPPS website (www.fbo.gov). No telephone requests will be accepted.
- Record
- SN00934331-W 20051120/051118211801 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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